YY/T 1551.3-2017Air filters for medical infusion and transfusion equipments - Part 3: Integrity test methods (English PDF)

Foreword

YY/T 1551 "infusion, blood transfusion device with air filter" consists of the following components.

--- Part 1. Aerosol bacterial retention test method;

--- Part 2. Liquid bacterial retention test method;

--- Part 3. Integrity test methods. This part of YY/T 1551 Part 3. This section drafted in accordance with GB/T 1.1-2009 given rules.

Introduction

For direct confirmation of infusion, blood transfusion devices with air filters to prevent the environment into the transfusion of microorganisms, blood transfusion system, a common method Liquid bacterial retention test and aerosol bacterial retention test two. The former is the first air filter in the filter by a special treatment, and then press Similar to the bacteriostasis-type liquid filter bacterial retention test method with a diameter of 0.3µm ~ 0.4µm, length 0.6µm ~ 1.0µm defects Pseudomonas bacteria challenge test, the specific test methods see the second part of this standard; the latter is the average particle diameter of about 3µm microbial aerosol simulation of clinical conditions of use challenge test, the specific test methods, see YY/T 1551 Part 1.

Air filters that pass the aerosol bacterial entrapment test are thought to effectively filter out airborne microbial aerosols. For nominal membrane pores The air filter with a diameter of 0.22 µm must meet the more stringent bacterial entrapment test requirements.

As the bacterial retention test method is more complicated, and the requirements of the test conditions and personnel to operate high, the general does not apply to the air filter Routine control test. Conventional control tests may use non-destructive physical integrity tests that have established correlation with the bacterial retention test Methods, such as bubble point pressure method. The air filter physical integrity test carried out on the premise that the air filter can withstand the corresponding bacteria interception test A correlation filter membrane bubble pressure was established. Bubble-point pressure, established on the basis of studies related to bacterial entrapment tests, can be used as infusion, transfusion Air bubble filter with integrity check bubble pressure. If the air filter integrity check bubble point pressure is lower than the membrane bubble point pressure, still with fine Bacteria retention test to establish correlation.

At present, infusion, blood transfusion devices with air filters are mainly air intake devices, liquid filter on the vent and other infusion, blood transfusion devices On the exhaust and other types. This standard mainly to the intake device, liquid filter on the vent as an example to establish air filter integrity experiment method.

1 Scope

YI/T 1551 provisions of this part of the infusion, blood transfusion device with air filter integrity test methods, including bubble point pressure test and water Breakthrough/penetration test.

2 Terms and definitions

The following terms and definitions apply to this document.

3 State conditioning and test environment

The sample should be conditioned for 24 h at (23 ± 2) ° C ambient temperature and (50 ± 5)% relative humidity and conditioned under conditions of conditioning test.

NOTE Sterilization of the filter will have some effect on the integrity of the filter, and the integrity test should be performed on the sterilized product.

4 Bubble point pressure test